Access AMH Instructions for Use Anti-Müllerian Hormone (AMH) © 2017 Beckman Coulter, Inc
Total Page:16
File Type:pdf, Size:1020Kb
ACCESS Immunoassay Systems Access AMH Instructions For Use Anti-Müllerian hormone (AMH) © 2017 Beckman Coulter, Inc. All rights reserved. B13127 FOR PROFESSIONAL USE ONLY Rx Only ANNUAL REVIEW Reviewed by Date Reviewed by Date PRINCIPLE INTENDED USE The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics. This system is intended to distinguish between women presenting with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve). The Access AMH is intended to be used in conjunction with other clinical and laboratory findings such as antral follicle count, before starting fertility therapy. The Access AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program. SUMMARY AND EXPLANATION Anti-Müllerian hormone (AMH) is a glycoprotein, which circulates as a dimer composed of two identical 72 kDa monomers that are linked by disulfide bridges. AMH belongs to the transforming growth factor-β family.1,2 AMH is named for its first described function in fetal sexual differentiation: a regression of the Müllerian ducts in males during early fetal life. In males, AMH is secreted by Sertoli cells of the testes. AMH concentrations are high until puberty, and then decrease slowly to residual post-puberty levels.3 This decline of AMH production during puberty is related to the pubertal development stage.4 In the early development of the female fetus, the absence of AMH allows the Müllerian ducts to further develop, resulting in the internal female anatomy.5 In females, AMH expression has been observed at approximately 36 weeks gestation in granulosa cells of preantral ovarian follicles and is produced by these cells until menopause.6,7 AMH concentrations in adult women reflect the number of small antral and preantral follicles entering the growth phase of their life cycle, which is proportional to the number of primordial follicles that still remain in the ovary, or the ovarian reserve.5,8,9 AMH decreases throughout a woman’s reproductive life, which reflects the continuous decline of Instructions For Use B15676 A English Access AMH DECEMBER 2017 Page 1 of 14 the oocyte/follicle pool with age and, accordingly, ovarian aging.10 Although AMH concentrations decrease with age, studies have shown that the day-to-day variability of AMH concentrations in menstruating women is low.11 AMH has been used in the evaluation of ovarian reserve.12 METHODOLOGY The Access AMH assay is a simultaneous one-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel, along with a mouse monoclonal anti-AMH antibody conjugated to alkaline phosphatase in MES buffer, TRIS buffered saline with proteins, and paramagnetic particles coated with a mouse monoclonal anti-AMH antibody in TRIS buffer. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by this reaction is measured with a luminometer. The light production is directly proportional to the concentration of AMH in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve. SPECIMEN SPECIMEN COLLECTION AND PREPARATION 1. Serum and plasma (lithium heparin) are the recommended samples. 2. Observe the following recommendations for handling, processing, and storing blood samples:13 • Collect all blood samples observing standard precautions for venipuncture. • Allow serum samples to clot completely before centrifugation in a vertical, closure up position. - Nonanticoagulated tubes containing gel or a clot activator should be stored in an upright position as soon as the mixing is complete. - Precentrifugation serum/cells contact time is according to tube manufacturer’s recommendations. Clotting may be slowed at cooler temperatures or if patient is on anticoagulant therapy. • Keep tubes stoppered at all times. • Physically separate serum or plasma from contact with cells as soon as possible. • Store samples tightly stoppered at room temperature (15 to 30°C) for no longer than 24 hours. • If the assay will not be completed within 24 hours, refrigerate the samples at 2 to 8°C. • If the assay will not be completed within 6 days, or for shipment of samples beyond 6 days, freeze at -20°C or colder. 3. Use the following guidelines when preparing specimens: • Ensure residual fibrin and cellular matter has been removed prior to analysis. • Follow blood collection tube manufacturer's recommendations for centrifugation. 4. Each laboratory should determine the acceptability of its own blood collection tubes and serum separation products. Variations in these products may exist between manufacturers and, at times, from lot-to-lot. 5. Thaw samples no more than two times. 6. Avoid assaying lipemic or hemolyzed samples. REAGENTS PRODUCT INFORMATION Access AMH Reagent Pack Cat. No. B13127: 100 determinations, 2 packs, 50 tests/pack Access AMH English Instructions For Use B15676 A Page 2 of 14 DECEMBER 2017 • Provided ready to use. • Store upright and refrigerate at 2 to 10°C. • Refrigerate at 2 to 10°C for a minimum of 2 hours before use on the instrument. • Stable until the expiration date stated on the label when stored at 2 to 10°C. • Stable at 2 to 10°C for 31 days after initial use. • Signs of possible deterioration are a broken elastomeric layer on the pack or control values out of range. • If the reagent pack is damaged (i.e., broken elastomer), discard the pack. R1a: Dynabeads* paramagnetic particles coated with monoclonal anti-AMH in TRIS buffer with surfactant, protein (bovine), < 0.1% sodium azide, 0.1% ProClin** 300. R1b: Anti-AMH alkaline phosphatase conjugate in MES buffer, surfactant, protein (bovine, recombinant), < 0.1% sodium azide, 0.1% ProClin 300. R1c: TRIS buffer with surfactant, protein (murine, bovine), < 0.1% sodium azide, 0.1% ProClin 300. *Dynabeads is a registered trademark of Dynal A.S., Oslo, Norway. **ProClin™ is a trademark of The Dow Chemical Company (“Dow”) or an affiliated company of Dow. WARNING AND PRECAUTIONS • For in vitro diagnostic use. • Patient samples and blood-derived products may be routinely processed with minimum risk using the procedure described. However, handle these products as potentially infectious according to universal precautions and good clinical laboratory practices, regardless of their origin, treatment, or prior certification. Use an appropriate disinfectant for decontamination. Store and dispose of these materials and their containers in accordance with local regulations and guidelines. • For hazards presented by the product refer to the following sections: REACTIVE INGREDIENTS and GHS HAZARD CLASSIFICATION. REACTIVE INGREDIENTS CAUTION Sodium azide preservative may form explosive compounds in metal drain lines. See NIOSH Bulletin: Explosive Azide Hazard (8/16/76). To avoid the possible build-up of azide compounds, flush wastepipes with water after the disposal of undiluted reagent. Sodium azide disposal must be in accordance with appropriate local regulations. GHS HAZARD CLASSIFICATION Instructions For Use B15676 A English Access AMH DECEMBER 2017 Page 3 of 14 AMH Particles (Compartment WARNING R1a) H317 May cause an allergic skin reaction. P280 Wear protective gloves, protective clothing and eye/face protection. P333+P313 If skin irritation or rash occurs: Get medical advice/attention. P362+P364 Take off contaminated clothing and wash it before use. reaction mass of: 5-chloro-2-methyl-4-isothiazolin -3-one [EC# 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC# 220-239-6](3:1) < 0.05% AMH Conjugate WARNING (Compartment R1b) H317 May cause an allergic skin reaction. P280 Wear protective gloves, protective clothing and eye/face protection. P333+P313 If skin irritation or rash occurs: Get medical advice/attention. P362+P364 Take off contaminated clothing and wash it before use. reaction mass of: 5-chloro-2-methyl-4-isothiazolin -3-one [EC# 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC# 220-239-6](3:1) < 0.05% AMH Sample Treatment Buffer WARNING (Compartment R1c) H317 May cause an allergic skin reaction. P280 Wear protective gloves, protective clothing and eye/face protection. P333+P313 If skin irritation or rash occurs: Get medical advice/attention. P362+P364 Take off contaminated clothing and wash it before use. reaction mass of: 5-chloro-2-methyl-4-isothiazolin -3-one [EC# 247-500-7] and 2-methyl-4-isothiazolin-3-one [EC# 220-239-6](3:1) < 0.05% Access AMH English Instructions For Use B15676 A Page 4 of 14 DECEMBER 2017 Safety Data Sheet is available at techdocs.beckmancoulter.com MATERIALS NEEDED BUT NOT SUPPLIED WITH REAGENT KIT 1. Access AMH Calibrators Provided at zero and approximately 0.16, 0.6, 4, 10, and 24 ng/mL (1.1, 4.3, 29, 71, and 171 pmol/L). Cat. No. B13128 2. Access AMH QC (Quality Control) or other commercially available control material. Provided at approximately 1, 5 and 15 ng/mL (7.1, 36 and 107 pmol/L). Cat. No. B13129 3. Access Sample Diluent A Vial Cat. No. 81908 Diluent Pack Cat. No. A79783 (For use with the UniCel DxI system onboard dilution feature.) 4. Access Substrate Cat. No. 81906 5. Access Wash Buffer II, Cat. No. A16792 UniCel DxI Wash Buffer II, Cat. No. A16793 EQUIPMENT AND MATERIALS R1 Access AMH Reagent Packs CALIBRATION CALIBRATION INFORMATION An active calibration curve is required for all tests. For the Access AMH assay, calibration is required every 31 days. Refer to the appropriate system manuals and/or Help system for information on calibration theory, configuring calibrators, calibrator test request entry, and reviewing calibration data.